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The coenzyme Q10 “saga”

In the fast-evolving world of food and health-food regulation, two recent court decisions deserve our attention as they rule in opposite direction a very interesting food regulatory case.

In both cases, a Chinese importer sold USA-imported CoQ10 capsules to Chinese consumers. The products had been imported as normal food after regular custom-clearance and CIQ inspection at entry port, and then put into the Chinese internal market.

However, coenzyme Q10 is a substance currently not clearly regulated in PRC law, and this triggered complaints launched by consumers, claiming that CoQ10 capsules cannot be sold as normal food in China.

1. CoQ10: A “special” substance

The products at stake are pills of coenzyme Q10 – also known as ubiquinone, ubidecarenone, or CoQ10. It is a substance naturally present also in the human cells, with important antioxidant functions, which can enhance anti-aging, cognitive and heart health functions. CoQ10 is sold as nutrition supplement in various countries, such as USA where it is certified as GRAS (Generally Recognized As Safe)[1].

CoQ10 is a substance listed as “coenzyme drug” (“辅酶类药”) in the official 2015 Chinese Pharmacopoeia[2]. The Chinese Pharmacopoeia is the official document providing standard for production and composition of drugs[3].

application documents for registration of CoQ10 Health Food shall also include
raw material CoQ10 detailed production process, quality reports and quality standards,
CFDA quality inspection report of raw material;
when CoQ10 is combined together with food, or other ingredients which are traditionally treated as both food and medicine, sufficient evidence shall be provided that CoQ10 will not react chemically with other raw materials. CoQ10 shall not be combined together with any other raw materials except food and ingredients which are traditionally treated as both food and medicine;
raw material CoQ10 should comply with the standards of Chinese Pharmacopoeia;
recommended intake of CoQ10 should not exceed 50mg/day;
allowed claims for products containing coenzyme CoQ10 are: alleviate physical fatigue, anti-oxidation, helps reduce blood fat and enhance immunity;
CoQ10 Health Food shall be labeled in compliance with health-food labeling regulation, and also include as not-suitable groups: “children, pregnant women, nursing mothers, persons with allergies”. In the "Precautions” space, it should be marked that "persons under medical treatment should consult a doctor before eating this food”.

Mr. Zhang had purchased several CoQ10 health food capsules from Boluo for a total price of RMB 740. Claiming that such products were not compliant with PRC law, Mr. Zhang asked for refund of the price plus a ten-fold penalty of RMB 7400.

Mr. Zhang had lost the first instance case, during which the court had rejected his requests mainly based on grounds that Mr. Zhang had not proven any health damages as a result of intake of such products.

In the second instance case, Mr. Zhang argued that:

Chinese law[6] does not require the plaintiff to prove any physical damages in order to claim the ten-fold punitive damages for non-compliance of food and drugs;

The first instance Court had focused only on whether Mr. Zhang’s health had been damaged, but had not taken into account the main issue: whether adding coenzyme CoQ10 to food products is compliant or not with PRC regulation.

Boluo defense was mainly based on the fact that (i) it had legally imported all such health-food products, which (ii) were successfully inspected by CIQ at import port, (iii) had duly obtained the sanitary certificate required for input into commerce in China and (iv) had regularly cleared customs.

The second instance court upheld the requests from Mr. Zhang, deeming that:

under article 62.1 of the PRC Food Safety Law[7] all imported food, food additives and food-related products shall conform to the national food safety standards of China;
under article 28.1 of the PRC Food Safety Law[8], production and commerce of food produced with non-edible raw materials, or food containing non-food-additive chemical substances and other substances potentially hazardous to human health is forbidden;
CoQ10 cannot be considered ordinary food/food ingredient because: (i) it belongs to coenzyme drugs according to Chinese Pharmacopoeia, (ii) it cannot be obtained through natural methods, and (iii) it is not a traditionally-eaten food in China;
although the products were regularly imported and inspected by CIQ, this does not imply complete compliance clearance with PRC food safety laws and regulations;
CoQ10 is tightly regulated under CFDA Notice n. 566/2009, which sets specific limits to the recommended daily intake, mark of not suitable groups, and requires prior CFDA approval when it is added into health-food. This confirms that products containing CoQ10 – such as those purchased by Mr. Zhang – have potential risks for health and must be sold under health-food regime;
In this scenario, as the products had been imported as normal food, they should be considered illegally sold in China.

CoQ10 is included in the Chinese Pharmacopoeia and considered as “drug”. Moreover, under notice 566/2009, the recommended daily intake should not exceed 50 mg/day;

In the specific case, not only the products were sold without health-food registration, but also the product does not comply with the CFDA recommended daily intake of 50 mg.

Niuhai appealed, and obtained a favorable decision by the Intermediate Court which completely overturned the first instance’s one.

The appeal court held, this time, that:

The involved goods can be sold legally after obtain the CIQ clearance. The involved products are imported from USA, have been positively inspected by CIQ, obtained the sanitation certificate, comply with PRC food safety requirements and are legally allowed to be sold;

The products are not food products with CoQ10 added; the products are rather just pure CoQ10 capsules, as its core ingredient is CoQ10;

CFDA Notice n. 566/2009 merely applies to the registration procedure of domestically-produced health-food, and cannot be considered as food safety standard;

Despite complain by Mr. Sun that the products violate PRC food safety standard, he was not able to prove any risk for the health.

4. Two different interpretation approaches

First of all we shall clarify that this kind of cases are rather frequent and decisions like Guangzhou Intermediate Court’s are the norm, while the one issued by the Shanghai’s Intermediate court is rather an exception. Moreover, based on the current draft of the Implementing Regulation of the Food Safety Law – not into force yet, though – it appears that cases similar to these will be decided in future in consistency with Guangzhou Intermediate Court’s decision.

Shanghai’s decision basically implies that food that could have health-food status can be imported and sold as normal food.

Even more significantly in our opinion, Shanghai decision also implies that the plaintiff should take the burden of proving that such food bears risks for health. In this case, a first assessment had already been done by CIQ, which tested the product and deemed that it posed no risk for health and it complied with PRC’s regulations. Briefly, it seems to us that the court has approached the law’s interpretation from a substantial - rather than formalistic – perspective, and considered that:

from regulation compliance perspective, PRC law does not clearly forbid adding CoQ10 into normal food;

from food safety perspective, Mr. Sun did not prove the existence of a risk[10] (important: the Court does not mention the need to prove harm to the health, but at least the existence of a risk). Which prove would have been sufficient, the Court does not say. We imagine that research papers, or official opinion by medical institutions might have been of help to Mr. Sun. Shanghai court deemed that an official safety assessment carried out by CIQ could not be overturned without a substantial element (the prove of risk).

Even from a formal perspective, Shanghai’s court decision can have its stand: despite generally accepted interpretation, art. 15 of the Supreme Court’s Judicial Interpretation on Issues concerning the Application of Laws relating to Food and Drug Disputes of 2014 does not expressly say that the claim by consumer against non-compliant food product must be upheld in the absence of physical damages or of risk. Shanghai’s court therefore has added one layer (to prove of potential risk, which is per se a mere potential element) to the application of article 148 of Food Safety Law, which in our opinion better adheres to the rationale of such provision.

Guangzhou’s Intermediate court, on the other hand, had a more formal approach to the law. As we have seen, it deems and implies that only health-food can contain “non-natural” ingredients, and that any other food containing those is non-compliant with PRC safety standards. Its decision implies that CIQ should have rejected the import of such food. Based on such assumption, the producer and/or distributor are liable for the 10-fold penalty without any need for the consumer to prove any real risk for health.

5. Grey areas in PRC food regulatory system and future evolution

In the end, these cases highlight a lack of internal coordination within PRC legal and administrative system.

Several authorities were involved: CFDA, with paramount competence on food safety; CIQ, with competence to clear import food products; NHFPC, in charge of carrying out risk assessment and issuing food safety standards; the Pharmacopoeia Commission, which approves and issues the Chinese Pharmacopoeia.

Despite clear improvement to the consistency of the PRC administrative food safety environment, vagueness in the relevant regulations as well as some confusion on the involved authorities’ powers and scope still exists:

provisions[11] of the Food Safety Law forbidding use of non-edible raw material or chemical substances into food remains – in the end – very vague. There is no – today – a clear list of (or criteria to identify) ingredients/substances that can be used only for health food and cannot be added to normal food;

food safety standards – issued by NHFPC – mention the role of CoQ10 in health-food but do not expressly forbid CoQ10 from being added into normal food;

Notice 566/2009 of CFDA merely “recommends” a maximum daily intake of CoQ10 when it is added into health food (not mentioning whether this recommendation is for health-safety purpose or for enhancing function purpose). Moreover the circular does not mention use of CoQ10 in normal food;

Chinese Pharmacopoeia defines CoQ10 as “coenzyme drug”. However, it is unlikely that this means that CoQ10 is considered as a drug at full extent (as vitamins are also defined in the Chinese Pharmacopoeia as “vitamin drugs”, but they can be legally sold as health-food and added into normal food as fortifiers).

On the other hand, as the implementation of the Food Safety Law is taking shape day by day[12], we can forecast that the correct categorization of products such as CoQ10 – as well as other similar regulatory issues – might be easier under the new regulatory framework.

In fact:

a catalogue of health food ingredients will be published. Such ingredients can be used only for production of health food, and cannot be contained in normal food (article 75 Food Safety Law; article 81 of the current draft Implementing Regulation of the Food Safety Law);

products containing ingredients only allowed for health-food might soon not be legally imported as ordinary food (art. 115 of the current draft Implementing Regulation of the Food Safety Law);

definition of health food provided by the current draft of the Implementing Regulation of the PRC Food Safety Law[13] seems more complete and rich that the current ones, as it refers to “food with health function claims, or for supplementing nutrients (such as vitamins/minerals), for regulating body functions, not intending to cure diseases, containing specific functional ingredients, suit for special groups of persons, and with fixed amount consumption.”

Therefore, should the CoQ10 be inserted in the health-food ingredients catalogue as a “sole health-food ingredient”, it will be crystal clear that current importation of such product as normal food will not be allowed anymore. At the same time, it will be clear that any different conduct by CIQ – allowing import of such product as normal food – will lack legal grounds.

[1] GRAS is a qualification provided under US law allowing additives or other ingredients to be used in food without a prior risk assessment by FDA.

[7] Such article has become article 92 in the revised 2015 Food Safety Law.

[8] Such article has become article 34 in the revised 2015 Food Safety Law.

[9] Decision n. 1878/2015 - (2015) 沪一中民一（民）终字第1878号

[10] In the decision, the term used is 危害

[11] Article 28 of Food Safety Law.

[12] The draft Implementing Regulations of the Food Safety Law have been published on December 9, 2015 and are currently undergoing to the public-comments phase, following which the draft might be modified and finally entry into force. Catalogue for Health-Food Ingredients and for Catalogue for Health-Food Claims are being drafted.

[13]Art. 195

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